United States Pharmacopeia/National Formulary (USP/NF)
U.S. Pharmacopeia / National Formulary：Pharmacopeia
Issuance history and latest edition
They are edited and published by the United States Pharmacopeial Convention under the U.S. government. The first edition of USP was published in 1820; from 1950, one revised edition was published every 5 years, until USP25 in 2002; from 2002, one edition is published every year, and it reaches the 41st edition by November 2017.
The first edition of NF was published in 1883; from 1980, the 15th edition was incorporated in USP, but they were still two parts, with USP being the first part and NF being the second part, to make the first USP20-NF15 combined volume; also from 2002, one edition is published every year, and it reaches the NF36 by November 2017.
Table 4 USP Publication Schedule
Characteristics of the USP
The USP is technical provisions of the U.S. government on the pharmaceutical product quality standards and testing methods, and serves as the legal basis for pharmaceutical production, use, management, and inspection. NF mainly contains the excipient standards.
USP/NF is currently divided into three volumes. Volume 1 includes Front Matter, General Notices, General Chapters, Reagents, Monographs, Reference Tables, Dietary Supplements, NF and Combined Index, etc.; Volume 2 and Volume 3 mainly include USP General Notices and Monographs content. The pharmaceutical product list in the monographs of the USP is in the alphabetical order of the legal drug names, and each pharmaceutical product entry mostly has drug name, structure formula, molecular formula, CAS registration No., ingredients and content description, package and storage specifications, identification method, loss on drying, residue on ignition, testing method, etc. The attached USP and NF combined index can be used to consult each drug in the USP-NF.
British Pharmacopoeia (BP)
Issuance history and latest edition
BP is a formal publication of the British Pharmacopoeia Commission, and importance source of the British pharmaceutical standards. It does not only furnish readers with medicinal and drug formulation standards and formula dispensing standards, but also presents them with many clearly classified and referenceable European pharmacopoeia monographs.
BP was born in 1864, and is the official collection of standards for UK medicinal products and pharmaceutical substances. A new edition of BP is published in August every year, and takes legal effect on January 1 of next year. It covers all standards in the European Pharmacopoeia and is updated three times per year online to include the European Pharmacopoeia supplements; it includes monographs for drug substances and formulated preparation, and monographs for herbal and veterinary drugs, etc. BP is named according to BP plus year, and the latest edition is BP2018.
Characteristics of BP
BP has 6 volumes in total
The specific content of BP includes:
General notices (providing general information applicable to all texts)
General monographs (applicable to all dosage forms)
Specific monographs providing mandatory standards for
1. Active pharmaceutical ingredients; 2. Excipients; 3. Formulated preparations (licensed and unlicensed products); 4. Herbal drugs, herbal drug products and herbal medicinal products; 5. Materials for use in the manufacture of homoeopathic preparations; 6. Blood-related products; 7. Immunological products; 8. Radiopharmaceutical preparations; 9. Surgical materials
Infrared reference spectra
Appendices
Supplementary chapters (providing additional guidance)
Comprehensive index
British Pharmacopoeia (Veterinary)
European Pharmacopoeia (EP)
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